Associate Director - CTMS (Irving)

SUMMARY : The Associate Director of eSource Development is responsible for managing the development and implementation of electronic source (eSource) solutions for clinical trials, ensuring that systems are optimized for efficiency and compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned . 1) Comply with all company policies, procedures, and conduct.

2) Strictly adhere to confidentiality and compliance standards.

3) Lead, manage, and mentor the eSource development team to ensure the successful implementation of electronic data capture solutions across all clinical trials. 4) Provide strategic direction, set performance goals, and foster a collaborative team environment

5) Oversee the design, development, and maintenance of eSource systems to capture clinical trial data efficiently and accurately, ensuring compliance with GCP, FDA, and other regulatory guidelines.

6) Work closely with clinical operations, regulatory, and data management teams to integrate eSource platforms into the broader clinical trial workflow

7) Continuously evaluate and enhance eSource processes to improve data accuracy, accessibility, and study efficiency. Implement best practices for system integration, data validation, and compliance.

8) Abstract data from research protocols and build into internal study shell. 9) Ensure that the eSource development team and clinical research staff are trained eSource systems, protocols, and workflows. Develop training materials and provide ongoing support to team members.

10) Develop and track performance metrics for eSource systems, analyzing data to inform decision-making and drive continuous improvement

11) Meet assigned targets, goals and completion deadlines.

12) Utilize analytical, problem solving and critical thinking

REQUIREMENTS

• Bachelors degree in Information Technology, Life Sciences, Clinical Research, or a related field (Masters degree preferred).
• Minimum of 8 years of experience in clinical research, with at least 3 years in eSource or electronic data capture (EDC) system development and implementation.
• Strong understanding of clinical trial processes, GCP, FDA regulations, and electronic data capture technologies.
• Experience managing teams and cross-functional collaboration, with a proven ability to lead and motivate technical staff in a fast-paced environment.
• Excellent communication, project management, and problem-solving skills.
• Knowledge of financial principles and experience working with study budgets is highly desirable.
• Strong attention to detail.
• Must be able to prioritize competing demands.
• Must possess excellent verbal and written communication skills.
• A proven ability to multi-task in a rapidly changing environment.